BASF launches digital solutions for the pharma industry during CPhI Worldwide 2019.

Fujifilm Diosynth Biotechnologies will add a new building, including gene therapy laboratories, to its facility in College Station, TX.

Schott and W.L. Gore introduced a prefillable, silicone-free glass syringe system, which won an award at CPhI Worldwide.

West introduced NovaPure 3-mL Cartridge components and the SmartDose Gen. II 10-mL injector.

The company showcased its compact robotic nest filling machine at CPhI Worldwide 2019 on Nov.–7 in Frankfurt, Germany.

The agreement paves the way for GSK’s specialty HIV company, ViiV Healthcare, to develop a broadly neutralizing antibody, N6LS, for HIV treatment and prevention.

The companies have entered into a clinical and commercial agreement to use MaxCyte’s ExPERT platform to enable development of up to five of Vor’s engineered cell therapies.

Bora announced the appointment of Samuel Ricchezza as president of its North American operations.

Rentshler Biopharma has begun its expansion project in the United States by putting a single-use bioreactor into operation at the Milford facility in Massachusetts.

During CPhI Worldwide in Frankfurt, Germany, Datwyler launched its Starter Pack, which features its Omni Flex stoppers and Prime Caps along with Schott’s adaptiQ vials, targeted at clients looking to tackle small quantity component needs.

Luxembourg-based company, C2 Pharma (C2P), has expanded its API and botanical extracts product portfolio with digoxin micronized grade and homatropine hydrobromide, and has multiple products under tech transfer and in development.

Beckman Coulter Life Sciences and IncellDx have announced a collaboration aimed at creating awareness for the oncology assays on the cytometry platform for European customers.

GE Healthcare Life Sciences has announced it will be working closely with Pharmadule Morimatsu to expand its KUBio “factory in a box” so that biopharma manufacturers will be able to quickly scale up vaccines, viral vector-based therapies, and other novel modalities.

Sangamo Therapeutics has revealed that the United Kingdom’s Medicines Healthcare Products Regulatory Agency (MHRA) has authorized the first in-human clinical trial evaluating a chimeric antigen receptor regulatory T cell (CAR-Treg) therapy.

According to the first annual resport into clinical trials by the Association of the British Pharmaceutical Industry, the United Kingdom is leading the rest of Europe in early-stage clinical research into new medicines and vaccines.

The agency sent a warning letter to Torrent Pharma after an inspection found violations of current good manufacturing practices that included a failure to thoroughly investigate batch failures.

Countries and partners have announced commitments to vaccinate 450 million children against polio each year and overcome barriers to reaching all children.

Xcelerate Development Services are complete solution services focused on de-risking development and ensuring speed-to-market.

The company introduced its new advanced elastomer, the 4040/40 formulation, and a new line extension of its AccelTRA component program, AccelTRA Select, at CPhI Worldwide from Nov. 5–7 in Frankfurt, Germany.

Through a partnership with the Sobti family, the CDMO will expand is injectable dosage form capabilities.

The new service will assist pharmaceutical companies with quality control and analytical requirements.

Catalent has named Mike Grippo as the new senior vice president, Strategy and Corporate Development, and Julien Meissonnier as vice president and chief scientific officer.

The guidance provides recommendations for the development and quality information that should be included in NDA and ANDA applications.

The approval of Givlaari (givosiran) is the first for treatment of acute hepatic porphyria, which results in the buildup of toxic porphyrin molecules during the production of heme.

The agency’s approval of Abrilada (adalimumab-afzb), a biosimilar to Humira, brings the total of approved biosimilars to 25.

A new sucrose product from MilliporeSigma has reduced nanoparticle impurities.

Hovione Technology worked with Harro Höfliger on powder filling of blisters for the reusable Papillon DPI.

The companies will work to discover and develop therapies for the treatment of liver-related cardio-metabolic diseases using Dicerna’s proprietary GalXC RNAi platform technology.